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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name culture media, general nutrient broth
510(k) Number K820796
Device Name #4001 TUBED MEDIA - FLUID THIOGLYCOLLATE
Applicant
BIOMEDICA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BIOMEDICA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number866.2350
Classification Product Code
JSC  
Date Received03/23/1982
Decision Date 04/08/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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